TEL AVIV, Israel--(BUSINESS WIRE)--Apr 19, 2010 - VBL
Therapeutics today announced positive results from preclinical and
Phase 1 studies evaluating the company's lead anti-cancer agent,
VB-111 – a first-in-class, targeted biological agent shown to
work via dual-action, anti-angiogenic and vascular disruptive
mechanism of action – in metastatic cancer.
Preclinical data evaluating VB-111 in a comprehensive set of in
vivo studies employing the Lewis Lung metastasis mouse model showed
the compound to be safe and specific, with a 90% reduction in tumor
burden of lung metastases after only one injection. A Phase 1 study
involving 27 patients with advanced stage solid tumors demonstrated
that VB-111 was well-tolerated with no dose-limiting toxicities,
and promising efficacy signals. These results were presented at the
American Association for Cancer Research (AACR) 101st
Annual Meeting 2010, taking place this week in Washington, D.C.

VB-111 is the first dual-action, anti-angiogenic and Vascular
Disruptive Agent (VDA) to use the company's proprietary platform
technology, its Vascular Targeting System (VTS™),
for cancer therapy. VB-111 is an IV-administered VDA that
works in a manner akin to a “biological knife” to
destroy tumor vasculature by cutting off the blood vessels feeding
the tumor. The targeting mechanism is confined to the tumor,
without damage to normal tissue blood vessels.

Preclinical data evaluating VB-111 in a comprehensive set of in
vivo studies employing the Lewis Lung metastasis mouse model showed
the compound to be safe and specific with activity only in the
metastatic lesion themselves. VB-111 induced a dose dependent
reduction of 90% in tumor burden of lung metastases with one
injection and similar efficacy in other tumor models. In this same
model, VB-111 showed better efficacy as compared to sunitinib
(Sutent®) 40 or 80 mg/kg. An additive effect was reached when
mice were treated with VB-111 and doxorubicin 2.5mg/kg.

“The mechanism behind this dual-action, anti-angiogenic
agent is truly unique, potentially allowing for enhanced
specificity and activity,” said Pierre Triozzi, M.D., Solid
Tumor Oncology Department, Cleveland Clinic, and the principal
investigator in the Phase 1 trial. “The preclinical findings
coupled with the safety and tolerability VB-111 demonstrated in the
Phase 1 patient study support the continued clinical evaluation of
the compound in specific tumor types of advanced metastatic cancer,
and underscores the potential for VB-111 as a broad-spectrum cancer
therapy.”

The Phase 1 clinical trial, conducted at The Cleveland Clinic
and The University of Texas Health Science Center at San Antonio,
evaluated the safety, PK, immune and tumor responses of a single,
intravenous administration of VB-111. The trial enrolled 27
patients with progressing, advanced solid tumors, with no existing
curative therapy, and adequate organ function and performance
status. There were six cohorts of patients evaluated in this trial;
cohorts one to five included three patients each, and cohort six
was expanded to 12 patients. Patients had frequent clinical and
laboratory safety evaluations. Tumor response was evaluated on day
28 and day 56.

VB-111 was found to be safe and well tolerated in these
patients. No dose-limiting toxicities were observed, and the
maximal tolerated dose has yet to be reached. Viral distribution,
cytokine and antibody response data supports repeat dosing at three
to six-week intervals. Both stable disease (SD) and partial
response (PR) were observed in the trial. On day 56 evaluation,
three of the 15 patients in cohorts one to five had SD; among the
12 patients in cohort six, four had SD on day 56, and one patient
(with papillary thyroid carcinoma) had a PR persisting for 12
months post dosing.

“VB-111 is a first-in-class vascular disruptive agent and
the lead oncotherapeutic borne out of our innovative, proprietary
Vascular Targeting System platform technology. VB-111 was designed
to target cancer tumors with a precision and specificity not seen
with currently available targeted therapies, which are often
associated with off-target safety issues and side-effects,”
said Professor Dror Harats, M.D., chief executive officer of VBL.
“The results we've seen with VB-111 thus far underscore the
potential of this innovative therapy to be utilized as a
broad-spectrum anticancer agent. We are pleased to be sharing this
research with the medical community here at AACR, and are excited
to initiate Phase 2 development of VB-111 later this
year.”

VBL is expected to launch Phase 2 clinical trials in 2010 in
thyroid cancer, as well as in a second indication later this
year.

About VB-111

VB-111 is a first-in-class, dual-action, anti-angiogenic and
Vascular Disruptive Agent (VDA) built upon VBL's proprietary
platform technology - the Vascular Targeting System (VTS™).
VTS enables control of gene expression that is both tissue and
condition specific, allowing for targeted and limited expression to
endothelial cells undergoing angiogenesis. VB-111 is an
IV-administered VDA that acts as a “biological knife”
to destroy blood vessels both feeding and surrounding the tumor,
resulting in shrinkage and tumor necrosis. Due to its high
selectivity and specificity, VB-111 avoids the involvement of
non-tumor vasculature and can be administered systemically without
the concern of toxicity and side effects associated with
non-specific treatments or commonly used chemotherapies.

About VBL Therapeutics

VBL Therapeutics is an innovative, clinical-stage biotechnology
company committed to the development of novel treatments for
immuno-inflammatory diseases and cancer. VBL has pioneered the
Lecinoxoid class of oral anti-inflammatory agents and VB-201 is the
lead candidate from this program, which has entered Phase 2
clinical development in patients with psoriasis. In addition, VBL
has a proprietary Vascular Targeting System (VTS™) technology
platform that has yielded VB-111, the first dual-action,
anti-angiogenic and vascular disruptive agent (VDA) for cancer,
which is expected to enter Phase 2 clinical trials in 2010. The
company was founded in 2000 and is based in Tel Aviv, Israel. VBL
has 55 granted patents and more than 115 patents pending. For more
information on the company, please visit
www.vblrx.com.

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